In the field of dental hygiene numerous devices and products have been developed to reduce and prevent gum disease and tooth decay. Gum disease typically results in the inflammation of the gum tissue by the accumulation of bacterial plaque on tooth surfaces and in particular on the tooth surface below the gum line. The plaque as well as the acids that decay teeth are produced by the sugars present in the mouth. Dental diseases can be often prevented with the use of mechanical, dietary, chemical and immunological plaque control. The toothbrush and dental floss in cooperation with a dentifrice are the usual convenient dental hygiene devices to control tooth decay and gum disease. These devices do have their limitations in effectively cleaning and treating some areas of the teeth. Other devices which have been produced include products that include a dentifrice or antibacterial product incorporated within the product. These products may be in the form of a chewable component, paste or a liquid such as a mouthwash.
One example of this type of product is disclosed in U.S. Pat. No. 4,554,154. This product includes a substrate of a malleable plastic or aluminum strip having a biologically acceptable adhesive on the outer surface of the strip. The malleable plastic is disclosed as a strip that covers and adapts to the shape of the tooth surfaces. The strip may be a chewable plastic strip, plastic foam shape, chewing stick, capsule or cloth, an encapsulated cleaning stick, toothbrush bristle containing many fine parallel fibers so that the bristle ends conform to the shape of the tooth surface, or a fiber chewing gum. The substrate may carry a biologically acceptable adhesive by impregnation, lamination, coating or encapsulation. The adhesive is disclosed as containing a remineralizing agent, immunological agent, enzyme, lysozyme or antibacterial agent. The plastic strip is intended to be chewed in a manner similar to chewing gum to treat the chewing surfaces of the teeth. This device does not effectively enter the spaces between the teeth or under the gum tissue to remove food particles and apply the dentifrice to the tooth surface.
U.S. Pat. No. 4,531,914 relates to a dental device for gingival retraction and gum conditioning prior to a subsequent dental procedure such as crowning. The dental device is disclosed as a moldable, flowable, coherent plastic material. In one embodiment, the disclosed material is a plastic thixotropic medium such as a hydrolyzed high polymer silicone that is rendered hydrosorbent by incorporating fibers into plastic. The balance and placement of the fibers and plastic are reported to be critical because the essential physical property of the medium is antithetical to the other and an imbalance renders the device ineffective. In use, the mass of thixotropic material is provided with a layer of the fibers to render the surface of the mass hydrosorbent. The fibers may be impregnated with a vascoconstricting agent to arrest bleeding of traumatized gingival tissue. The material is pressed into place to push gingival flap away from the tooth surface and remove any fluids from the area to enable the dental procedure to proceed. This device does not apply dentifrices to the tooth surface and does not remove plaque and debris from between the teeth.
U.S. Pat. No. 3,138,820 relates to a tooth cleaning and gum massaging device in the form of a strip or pellet of a sponge-like material that expands in the presence of moisture. The material is disclosed as a cellular body having a dentifrice, germicide, or medicament. The device is chewed to massage the gums and to release the dentifrice through the pores of the sponge-like material.
U.S. Pat. No. 3,964,164 relates to a material for applying preventive and therapeutic agents to the teeth of a patient. The material is disclosed as a moldable mass as a carrier which may contain an active agent. The moldable carrier may be a plastic or elastic impression mass such as impression wax or wax compositions, hydrocolloidal impression masses and rubber impression masses. The molding material may further be a gelatin or agar having a calcium sulfate reactor. In the disclosed embodiments the molding material is initially plastic to be applied to the teeth and conform to the tooth surface. The molding material is then allowed to set or polymerize into a tough or viscous material. This product has the disadvantage of requiring the user to mix or heat the components of the molding material to activate the setting action of the material. The material must further be molded quickly when activated to prevent the material from hardening before being shaped.
U.S. Pat. No. 4,650,665 relates to an absorbable biologically compatible putty-like composition used as a matrix from which immunologically or pharmacologically active agents can be introduced into the body to provide sustained release of the agent. The disclosed matrix is a mixture of calcium stearate, dextran and castor oil. Dextran is disclosed as the most preferred absorption enhancing agent.
U.S. Pat. No. 3,598,123 relates to a bandage for administering drugs by absorption. The device includes a backing member including a pressure-sensitive adhesive. A systemically active drug is encapsulated in microcapsules which are distributed throughout the adhesive. The encapsulating material is disclosed as polyvinyl alcohol, polyvinylacetate, collagen, wax, silicon rubbers and others.
Other types of dental treating devices include those which have a shaped member to conform to the teeth of the user. These devices often have a foam or sponge-like material that can be formed and shaped around the teeth to deliver a dentifrice or other material. Some of these devices include a substantially horse shoe-shaped tray to apply a dentifrice to the teeth. Examples of these devices may be found in U.S. Pat. No. 3,339,547, U.S. Pat. No. 3,844,286, U.S. Pat. No. 3,527,219, U.S. Pat. No. 3,416,527, U.S. Pat. No. 3,688,406 and U.S. Pat. No. 3,379,193.
The above-noted devices and compositions do not provide a convenient and effective means for removing food particles from between the teeth and for applying a dentifrice or medicament to the tooth surface below the gum line. Many of these devices cannot be easily molded and cannot be comfortably worn by the user. Some of the molding compositions which have been previously used require heat or chemical activation which increases the burden of using the composition. The present invention is directed to a composition that is easily molded to conform to the contours of the teeth and gums to apply a dentifrice to the tooth surface under the gum line.